cGMP Clinical and Commerical Manufacturing

Cognate Operates a commercial scale cGMP Compliant Manufacturing Facility in Memphis, TN, within 10 minutes of a FedEx superhub capable of servicing North America, South America and Europe.

  • Cognate has assembled a world-class team of experts across all departments within its organization to fully leverage our commercial capacity for autologous and allogeneic cell and  cell-mediated gene therapies.
  • Our team has unparalleled experience in the regenerative medicine and cell and gene immunotherapy fields with experience in the most diverse range of cell types and therapies, including but not limited to: CAR-T, TCR, TIL, MIL, DC, NK cell, MSC, hUC-MSC’s and others.
  • 3 suite configurations:
    • Validated Production Suites that are US FDA cGMP compliant and in use for cell therapy production since 2007. All of these suites can be used for regular cell culture and bacterial or viral cell culture purposes as needed
    • Validated Production suites in production since 2017 that are both US FDA and EU Annex 1 compliant for use with regular cell culture
    • Validated Production suites in production since 2017 that are both US FDA and EU Annex 1 compliant for use with regular cell culture but with an extra containment ante-room in support of bacterial or viral cell culture purposes as needed
  • Quality Control (QC), Innovation, Assay Development and Process Development (PD) Laboratories to support a variety of your needs, including but not limited to: upfront activities related to commencing manufacturing; validation of qualification and/or release assays; moving all or part of the manufacturing process to new state of the art equipment; incorporating automation or other forms of closed systems into the manufacturing process; scale-up activities; or optimizing the manufacturing process to meet commercial standards.

Our Comprehensive Package of Cell-Based cGMP Product Manufacturing Services:

  • cGMP production of cells for clinical and commercial application from a variety of starting materials, including whole blood, apheresis, leukapheresis, bone marrow, tumor tissue, umbilical cord, adipose tissue, MCB, WCB, single clone stocks among others.
  • Scale up of production from smaller scale clinical production to later stage clinical trial and/or commercial scale, from 1 production suite all the way to a custom configuration dedicated capacity model.
  • Incorporation of a wide variety of technology into the manufacturing process. Cognate has expertise in and is skilled in all types of technology.Our clients are free to adopt the technology they wish to work with – Cognate provides a flexible and bespoke operating model, allowing each client to use the tools best suited to each client’s specific product.
  • Preparation of cGMP Master and Working cell banks
  • Fill-finish services
  • A variety of different types of customized cryopreservation options including additional process development and optimization that determines the optimal cryopreservation protocol for the product.
  • Manufacturing process validation from design to implementation
  • Materials management and supply chain scheduling and integration
  • Preparation of raw material specification, SOPs and batch production records
  • Shipping and stability validation protocols
  • Quality control testing
    • cGMP assay transfer to QC and assay qualification/validation
    • Bioburden, mycoplasma and endotoxin testing
    • Design and implementation of product release QC testing and characterization assays (including functionality assays)
    • Stability testing for customized cell culture reagents and products